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Completed

NCT Number: NCT05098925

Study of Thermoregulatory Processes in Ultra-endurance Runners in a Hot and Humid Environment

Human beings are characterized by their extraordinary ability to thermoregulate.

During a physical exercise, only 20% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 80% is released as heat. In temperate environments, so-called metabolic heat is dissipated by several physical phenomena (radiation, conduction, convection and evaporation). However, if the dissipation capacity (in a hot and humid environment for example) is lower than the production of metabolic heat, the body temperature increases progressively until exercise stops or heat-related pathologies develop. This pathological entity defined by the acronym EHI for Exertional Heat Illness gather a wide spectrum of clinical forms ranging from oedema or heat rash, to muscle cramps, to syncope; up to more serious forms such as heat exhaustion or heat stroke during exercise.

Heatstroke during exercise is the second most common cause of death in athletes after heart disease.

However, the results of the epidemiological studies and the recommendations are limited to events with effort durations or distances not exceeding those of the marathon. They therefore do not consider ultra-endurance disciplines.

These disciplines, defined by durations of effort of at least 6 hours, have specific characteristics (duration of effort, intensity, steep gradients, exotic destinations, extreme environments) which means that extrapolation of the results and knowledge of the physiology of thermoregulation from "classic" endurance events, such as marathons, to ultra-endurance events is hazardous. There are therefore significant areas of uncertainty in understanding the thermoregulatory function, prevalence of EHI (Exertional Heat Illness) and health implications of ultra-endurance running in a hot environment. This is the context of ERUPTION-2.

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Key information

Conditions

Intensive Sport

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Réunion

Saint-Denis, 97400, Reunion

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Runners participating in " La diagonale des fous " race of the "Grand Raid" 2021 on Reunion Island

Exclusion criteria

  • Runners who do not understand French

Treatment and study plan

Biological testing

Other

Blood sampling, microcapillary sampling, temperature monitoring, saliva testing, EHI questionnaire

Primary outcomes

  1. Core temperature measurement

    Time frame: during 3 days of the race

    Measure of core temperature (°C) will be carried out by continuous monitoring using e-Celsius performance Bodycap technology sensors carried by the athletes through the race

  2. Natremia measurement

    Time frame: during 3 days of the race

    Measure of natremia (blood sodium concentration) will be made by 5 measurements carried out on the eve of the start and during the race, by microcapillary blood sample using the i-STAT technology and CHEM8+ cartridges.

  3. Hydration saliva measurement

    Time frame: during 3 days of the race

    Hydration will be measured 5 times carried out on the eve of the start and during the race using saliva sample to measure the salivary osmolarity with the MX3 testing device.

  4. Hydration by weight measurement

    Time frame: during 3 days of the race

    Weight in kg will be measured 5 times carried out on the eve of the start and during the race

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: ERUPTION-2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2021
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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